What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as sitagliptin, exenatide, liraglutide, semaglutide, and insulin, have various side effects. Sitagliptin may cause upper respiratory infections, headaches, and gastrointestinal issues. Exenatide and liraglutide, which are GLP-1 receptor agonists, can lead to nausea, vomiting, diarrhea, and potential risk of pancreatitis. Semaglutide, another GLP-1 receptor agonist, shares similar side effects and may also cause thyroid tumors. Insulin therapy can result in hypoglycemia, weight gain, and injection site reactions. Continuous glucose monitoring itself is generally safe but may cause skin irritation at the sensor site.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of Type 2 Diabetes, focusing on improving glycemic control. Metformin is often the first-line treatment due to its efficacy and safety profile. Other approved medications include SGLT2 inhibitors, which help lower blood glucose by preventing glucose reabsorption in the kidneys, and GLP-1 receptor agonists, which enhance insulin secretion and inhibit glucagon release. Insulin therapy, including basal and premixed insulin, is also used, particularly in patients with advanced disease. Continuous Glucose Monitoring (CGM) systems, while not a drug, are FDA-approved devices that provide real-time glucose monitoring, helping patients and healthcare providers make informed decisions to improve glycemic control.

What other types of research exist?

Promising novel alternatives to Continuous Glucose Monitoring for Type 2 Diabetes patients include: 1) GLP-1 receptor agonists such as semaglutide and dulaglutide, which have shown significant improvements in glycemic control. 2) SGLT2 inhibitors, which not only help in glycemic control but also offer cardiovascular and renal benefits. 3) Telemedicine interventions, which have been shown to modestly reduce A1C levels and improve diabetes management through remote consultations and monitoring.

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Continuous Glucose Monitoring

CGM for Diabetes after Kidney Transplant

N/A

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or above

Person with Type 2 Diabetes and on insulin

Must not have

Presence of clinically unstable cardiovascular disease

Active malignancy treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 70 days

Summary

This trial studies how a new technology can help people with diabetes who have had a kidney transplant manage their blood sugar levels more effectively. The technology provides constant data on blood sugar, allowing for better management.

Who is the study for?

This trial is for adults over 18 with Type 2 Diabetes who use insulin and have had a kidney transplant within the last year. Participants need functioning kidneys, access to home Wi-Fi, and must be able to test their blood sugar four times daily if using the blinded CGM. It's not for those with Type 1 Diabetes, unstable heart disease, active cancer treatment, significant visual or cognitive issues, or women who are pregnant/breastfeeding.

What is being tested?

The study examines how continuous glucose monitoring (CGM) affects blood sugar control in diabetic kidney transplant patients. The Dexcom G6 device will be used to monitor glucose levels continuously to see if it helps maintain them within a target range.

What are the potential side effects?

While the Dexcom G6 generally has minimal side effects as it's non-invasive, potential issues may include skin irritation at the sensor site or allergic reactions. Incorrect readings can occur but are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have Type 2 Diabetes and am taking insulin.

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I had a kidney transplant within the last year and my kidney is working well.

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I had a kidney transplant within the last year and my kidney works well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart problems that are not well-controlled.

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I am currently receiving treatment for cancer.

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I have significant issues with my vision or thinking.

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I am currently taking hydroxyurea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 70 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~70 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 70 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time in Range (70-180 mg/dl)

Secondary study objectives

Adherence to Diabetic Diet

CGM satisfaction questionnaire (10 questions)

Glycemic variability

+2 more

Other study objectives

safety endpoint Hypoglycemia

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Continuous glucose monitoring (CGM)Active Control1 Intervention

Those in the intervention arm will wear a continuous glucose monitoring device. They only need to perform blood glucose fingersticks if the CGM transmission is lost for a prolonged period of time or in cases of hypo- or hyperglycemia when symptoms don't align with blood glucose readings.

Group II: Self monitoring of blood glucose (fingersticks)Placebo Group1 Intervention

The control arm will remain on standard-of-care SMBG while the intervention arm will use their CGM. The control arm utilizing SMBG will be required to have at minimum 4 glucose checks per day.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 2 Diabetes work through various mechanisms to improve glycemic control. Metformin decreases hepatic glucose production and increases insulin sensitivity. Sulfonylureas stimulate insulin secretion from pancreatic beta cells. Insulin therapy directly provides the hormone that the body is deficient in, helping to regulate blood glucose levels. GLP-1 receptor agonists enhance glucose-dependent insulin secretion and slow gastric emptying, which helps to reduce postprandial glucose spikes. DPP-4 inhibitors prevent the breakdown of incretin hormones, thereby increasing insulin release and decreasing glucagon levels. Continuous glucose monitoring (CGM) plays a crucial role by providing real-time data on glucose levels, allowing for more precise adjustments in therapy and lifestyle, ultimately leading to better glycemic control and reduced risk of complications.

Type 2 diabetes mellitus: a review of pharmacological treatment.Approaches to the management of postprandial hyperglycaemia.